Skip to content

The efficacy and safety of tacrolimus monotherapy in idiopathic membranous nephropathy: a randomized, controlled, open-label, multi-centre clinical study

The efficacy and safety of tacrolimus monotherapy in idiopathic membranous nephropathy: a randomized, controlled, open-label, multi-centre clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015583
Enrollment
Unknown
Registered
2018-04-09
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic membranous nephropathy

Interventions

1:TAC monotherapy
2:TAC plus steroid treatment

Sponsors

Renal Division, Department of Internal Medicine, Shanghai Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-80 years; 2) Renal biopsy proven IMN (Stage I-IV); 3) Proteinuria >4g/24hr or serum albumin100 RU/ml or eGFR decline =30% when IMN diagnosed within 6~12 months; 4) eGFR>30 ml/min/1.73m2; 5) Inform consent signed.

Exclusion criteria

Exclusion criteria: 1) Renal biopsy findingsinterstitial fibrosis >50%; 2) Infectious disease including uncontrolled hepatitis b, hepatitis c, tuberculosis, HIV; 3) Active GI ulcer within 3 months of randomization; 4) Untreated malignancy; 5) Received steroid or immunosuppressant within 3 months of screening; 6) ALTAST?total bilirubin more than 1.5 fold of normal range; 7) Critical conditions such as severe infection, MODS etc.; 8) Pregnancy or lactation; 9) Known allergic to intervention drugs; 10) Enrolled in other clinical studies within 3 months of randomization; 11) Unsuitable to be enrolled in the study judged by the investigator.

Design outcomes

Primary

MeasureTime frame
24hr proteinuria remission rate;

Secondary

MeasureTime frame
Serum PLA2R;24hr proteinuria level;serum albumin;

Countries

China

Contacts

Public ContactGengru Jiang

Renal Division, Department of Internal Medicine, Shanghai Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

jianggeng-ru@hotmail.com+86 13651605926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026